Pancreas CancerMULTIDOMNCT04263948
Multidom Remote Monitoring of Patient With Advanced Pancreatic Cancer Treated With Florinox Using the PiCaDo Plateform
A study testing Picado system internet platform and connected objects in people with Pancreas Cancer, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Pancreatic cancer is a rapidly developing cancer with a poor prognosis. The mFOLFIRINOX protocol has become the standard medical treatment for this pathology. However, mFOLFIRINOX is the cause of severe toxicities including leukoneutropenia, thrombocytopenia, diarrhea, nausea-vomiting, anorexia, asthenia, weight loss… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Picado system internet platform and connected objects
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Histological or cytological diagnosis of pancreatic adenocarcinoma
- Locally advanced or metastatic pancreatic cancer
- With or without previous surgery (pancreas and / or metastases)
- Performance status of 0 or 1 according to WHO
- Age between 18 and 85 years old included
- No history of prior chemotherapy or radiotherapy
Show all 13Show fewer
- Absence of cutaneous or mucosal jaundice or skin pruritus
- No proven thrombosis
- Absence of heart disease or other pathology poorly controlled by current treatments
- Bilirubinemia and alkaline phosphatases <1.5 ULN (with or without stent)
- Hematological, renal and hepatic laboratory tests authorizing the administration of mFOLFIRINOX
- Affiliated subject or beneficiary of a social security scheme
- Patient who freely signed informed consent
Who cannot join
- Immediately resectable pancreatic cancer
- No histological or cytological evidence of pancreatic adenocarcinoma
- Performance status> 1 (WHO)
- Age <18 and> 85 years old
- Prior administration of chemotherapy or radiotherapy
- Skin jaundice and / or pruritus
Show all 14Show fewer
- Uncontrolled venous or arterial thrombosis
- Co morbidity not controlled by a specific treatment
- Biological anomalies contraindicating the administration of one or more drugs which make up FOLFIRINOX
- Lack of GPRS coverage in the home
- Patient participating in another clinical study
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant, lactating or parturient woman
- Patient hospitalized without consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multidom Remote Monitoring of Patient With Advanced Pancreatic Cancer Treated With Florinox Using the PiCaDo Domomedecine Plateform
Pancreatic cancer is a rapidly developing cancer with a poor prognosis. The mFOLFIRINOX protocol has become the standard medical treatment for this pathology. However, mFOLFIRINOX is the cause of severe toxicities including leukoneutropenia, thrombocytopenia, diarrhea, nausea-vomiting, anorexia, asthenia, weight loss and peripheral sensory neuropathy. Therefore, its indication is limited to patients in good general condition. In practice, it is often interrupted upon the occurrence of hematological and/or clinical grade 3-4 toxicities, Remote patient tele-monitoring of symptoms (Patient Reported Outcomes), body weight, circadian rhythms, sleep and activity would allow the identification of early warning signals reflecting deterioration or improvement in the health of these fragile patients, and trigger proactive interventions, while they are outside the hospital. Thus, the MultiDom study proposes a comprehensive tele-monitoring and telecare strategy that would complement standard of care over a 7-weeks period to 42 consenting patients. The patients receive neoadjuvant or first line chemotherapy with mFOLFIRINOX for advanced or metastatic pancreatic cancer at one of four centres in Ile-de-France region (France).
Read the detailed description
MultiDom stands up among the very first prospective patient-entered and multidimensional, multiactor and multicenter study, that assesses the qualitative and quantitative impact of mFOLFIRINOX on the daily life of patients with pancreatic cancer in real time. Main endpoint is the rate of patients undergoing toxicity-related emergency hospitalisations, and the objective is to reduce it to <10%. Telemonitored data-based proactive interventions will expectedly prevent worsening of patients 'health, and maintain their chances of disease control on effective mFOLFIRINOX chemotherapy.
Participating patients have usual follow up and treatments for their disease, but also: wear a chest sensor that measures and teletransmits accelerometry, surface temperature and 3D-orientation every min, weigh themselves daily on a BLE-balance, with immediate weight tele transmission, and fill out electronic PRO questionnaires daily using a telecommunicating tablet.
All data are tele transmitted to an approved health data hub, and automatically analysed for physical activity, sleep, circadian rhythms, symptoms scores trends in real time. Visualization screens and alerts are generated according to preset thresholds, and medical team responses are traced.
Currently recruiting centres:
- Clinique du Mousseau, Evry, France
- Hospital Paul Brousse (Assistance Publique-Hôpitaux de Paris), Villejuif, France
- Clinique St-Jean L'Ermitage, Melun, France
- Private Hospital of Antony, Antony, France
- Conditions
- Pancreas Cancer
- Being tested
- Picado system internet platform and connected objects
- Keywords
- pancreas cancer, Plateform monitoring, metastatic or "borderline", telemedicine, tele monitoring, telecare, emergency hospitalisations, patient-centered medicine, internet platform, circadian rhythms, chronotherapy, physical activity, sleep, patient -reported outcomes, symptoms, quality of life, compliance, sensors, electronic questionnaires
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis, Motor Activity, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Picado system internet platform and connected objectsDevice
The system will monitor the circadian rhythms, physical activity, sleep, symptoms and body weight of patients with advanced pancreatic cancer during one week before (baseline) and six weeks after the 1st course of standard mFOLFIRINOX. The reach of preset thresholds for several parameters that are automatically computed will trigger alerts toward approved health professionals, and their responses will be traced.
| Study group | Role | What they receive |
|---|---|---|
| Picado Arm | Experimental | All the patients undergo multidimensional tele monitoring for 7 weeks using an upgraded version of the Picado internet platform Receives: Device: Picado system internet platform and connected objects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity-related emergency hospitalisation rate
The main objective is to assess the toxicities occurring during the 6 weeks following the start of the 1st cycle of FOLFIRINOX in conventional administration in patients benefiting from the PiCADo telemonitoring system.
Measured: First cycle of treatment of 6 weeks
Rates and grades toxicity and early tumor responses
Secondary objectives include rates and grades of toxicity and early tumor responses, as well as PiCADo platform performances and users perceptions.
Measured: First cycle of treatment of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Jun 2021
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Faculty of Medicine Paris Saclay University, Altran, Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263948
- Sponsor's protocol ID
- 2017-12-033
- Acronym
- MULTIDOM
- Status last verified
- Jul 2026
- First submitted
- 7 Feb 2020
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the original trial report manuscripts will be shared after deidentification. Supportive information will consist in the study protocol.
Publications
Bouchahda M, Komarzynski S, Ulusakarya A, Attari A, Duprès A, Breda G, Fritsch A, Adam R, Lévi F (2020) Improving FOLFIRINOX safety in pancreatic cancer patients through multidimensional remote monitoring and proactive care using a domomedecine mobile platform. J Clin Oncol 38: TPS4673.
Levi F, Komarzynski S, Huang Q, Young T, Ang Y, Fuller C, Bolborea M, Brettschneider J, Fursse J, Finkenstadt B, White DP, Innominato P. Tele-Monitoring of Cancer Patients' Rhythms during Daily Life Identifies Actionable Determinants of Circadian and Sleep Disruption. Cancers (Basel). 2020 Jul 17;12(7):1938. doi: 10.3390/cancers12071938.
PubMed 32708950Innominato P, Komarzynski S, Karaboue A, Ulusakarya A, Bouchahda M, Haydar M, Bossevot-Desmaris R, Mocquery M, Plessis V, Levi F. Home-Based e-Health Platform for Multidimensional Telemonitoring of Symptoms, Body Weight, Sleep, and Circadian Activity: Relevance for Chronomodulated Administration of Irinotecan, Fluorouracil-Leucovorin, and Oxaliplatin at Home-Results From a Pilot Study. JCO Clin Cancer Inform. 2018 Dec;2:1-15. doi: 10.1200/CCI.17.00125.
PubMed 30652550Bouchahda M, Ulusakarya A, Thirot-Bidault A, Attari A, Bossevot R, Tuligenga R, Hammel P, Adam R, Levi F. Multicentre, interventional, single-arm study protocol of telemonitored circadian rhythms and patient-reported outcomes for improving mFOLFIRINOX safety in patients with pancreatic cancer (MultiDom, NCT04263948). BMJ Open. 2023 Jun 7;13(6):e069973. doi: 10.1136/bmjopen-2022-069973.
PubMed 37286324
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidom Remote Monitoring of Patient With Advanced Pancreatic Cancer Treated With Florinox Using the PiCaDo Domomedecine Plateform
- ClinicalTrials.gov ID
- NCT04263948
- Acronym / sponsor ID
- MULTIDOM / 2017-12-033
- Conditions
- Pancreas Cancer
- Keywords
- pancreas cancer, Plateform monitoring, metastatic or "borderline", telemedicine, tele monitoring, telecare, emergency hospitalisations, patient-centered medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Faculty of Medicine Paris Saclay University, Altran, Assistance Publique - Hôpitaux de Paris
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pancreatic cancer is a rapidly developing cancer with a poor prognosis. The mFOLFIRINOX protocol has become the standard medical treatment for this pathology. However, mFOLFIRINOX is the cause of severe toxicities including leukoneutropenia, thrombocytopenia, diarrhea, nausea-vomiting, anorexia, asthenia, weight loss and peripheral sensory neuropathy. Therefore, its indication is limited to patients in good general condition. In practice, it is often interrupted upon the occurrence of hematological and/or clinical grade 3-4 toxicities, Remote patient tele-monitoring of symptoms (Patient Reported Outcomes), body weight, circadian rhythms, sleep and activity would allow the identification of early warning signals reflecting deterioration or improvement in the health of these fragile patients, and trigger proactive interventions, while they are outside the hospital. Thus, the MultiDom study proposes a comprehensive tele-monitoring and telecare strategy that would complement standard of care over a 7-weeks period to 42 consenting patients. The patients receive neoadjuvant or first line chemotherapy with mFOLFIRINOX for advanced or metastatic pancreatic cancer at one of four centres in Ile-de-France region (France).
Detailed description
MultiDom stands up among the very first prospective patient-entered and multidimensional, multiactor and multicenter study, that assesses the qualitative and quantitative impact of mFOLFIRINOX on the daily life of patients with pancreatic cancer in real time. Main endpoint is the rate of patients undergoing toxicity-related emergency hospitalisations, and the objective is to reduce it to <10%. Telemonitored data-based proactive interventions will expectedly prevent worsening of patients 'health, and maintain their chances of disease control on effective mFOLFIRINOX chemotherapy.
Participating patients have usual follow up and treatments for their disease, but also: wear a chest sensor that measures and teletransmits accelerometry, surface temperature and 3D-orientation every min, weigh themselves daily on a BLE-balance, with immediate weight tele transmission, and fill out electronic PRO questionnaires daily using a telecommunicating tablet.
All data are tele transmitted to an approved health data hub, and automatically analysed for physical activity, sleep, circadian rhythms, symptoms scores trends in real time. Visualization screens and alerts are generated according to preset thresholds, and medical team responses are traced.
Currently recruiting centres:
- Clinique du Mousseau, Evry, France
- Hospital Paul Brousse (Assistance Publique-Hôpitaux de Paris), Villejuif, France
- Clinique St-Jean L'Ermitage, Melun, France
- Private Hospital of Antony, Antony, France
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Picado Arm | Experimental | Device: Picado system internet platform and connected objectsAll the patients undergo multidimensional tele monitoring for 7 weeks using an upgraded version of the Picado internet platform |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- -Histological or cytological diagnosis of pancreatic adenocarcinoma
- Locally advanced or metastatic pancreatic cancer
- With or without previous surgery (pancreas and / or metastases)
- Performance status of 0 or 1 according to WHO
- Age between 18 and 85 years old included
Key exclusion criteria (14 listed)
- Immediately resectable pancreatic cancer
- No histological or cytological evidence of pancreatic adenocarcinoma
- Performance status> 1 (WHO)
- Age <18 and> 85 years old
- Prior administration of chemotherapy or radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Picado system internet platform and connected objectsThe system will monitor the circadian rhythms, physical activity, sleep, symptoms and body weight of patients with advanced pancreatic cancer during one week before (baseline) and six weeks after the 1st course of standard mFOLFIRINOX. The reach of preset thresholds for several parameters that are automatically computed will trigger alerts toward approved health professionals, and their responses will be traced. | Device | Picado Arm |
Primary outcome
Toxicity-related emergency hospitalisation rate
Time frame: First cycle of treatment of 6 weeks
The main objective is to assess the toxicities occurring during the 6 weeks following the start of the 1st cycle of FOLFIRINOX in conventional administration in patients benefiting from the PiCADo telemonitoring system.
Rates and grades toxicity and early tumor responses
Time frame: First cycle of treatment of 6 weeks
Secondary objectives include rates and grades of toxicity and early tumor responses, as well as PiCADo platform performances and users perceptions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- BackgroundBouchahda M, Komarzynski S, Ulusakarya A, Attari A, Duprès A, Breda G, Fritsch A, Adam R, Lévi F (2020) Improving FOLFIRINOX safety in pancreatic cancer patients through multidimensional remote monitoring and proactive care using a domomedecine mobile platform. J Clin Oncol 38: TPS4673.
- Background: PubMed 32708950Levi F, Komarzynski S, Huang Q, Young T, Ang Y, Fuller C, Bolborea M, Brettschneider J, Fursse J, Finkenstadt B, White DP, Innominato P. Tele-Monitoring of Cancer Patients' Rhythms during Daily Life Identifies Actionable Determinants of Circadian and Sleep Disruption. Cancers (Basel). 2020 Jul 17;12(7):1938. doi: 10.3390/cancers12071938.
- Background: PubMed 30652550Innominato P, Komarzynski S, Karaboue A, Ulusakarya A, Bouchahda M, Haydar M, Bossevot-Desmaris R, Mocquery M, Plessis V, Levi F. Home-Based e-Health Platform for Multidimensional Telemonitoring of Symptoms, Body Weight, Sleep, and Circadian Activity: Relevance for Chronomodulated Administration of Irinotecan, Fluorouracil-Leucovorin, and Oxaliplatin at Home-Results From a Pilot Study. JCO Clin Cancer Inform. 2018 Dec;2:1-15. doi: 10.1200/CCI.17.00125.
- Derived from this study: PubMed 37286324Bouchahda M, Ulusakarya A, Thirot-Bidault A, Attari A, Bossevot R, Tuligenga R, Hammel P, Adam R, Levi F. Multicentre, interventional, single-arm study protocol of telemonitored circadian rhythms and patient-reported outcomes for improving mFOLFIRINOX safety in patients with pancreatic cancer (MultiDom, NCT04263948). BMJ Open. 2023 Jun 7;13(6):e069973. doi: 10.1136/bmjopen-2022-069973.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the original trial report manuscripts will be shared after deidentification. Supportive information will consist in the study protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Picado system internet platform and connected objects in people with Pancreas Cancer, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity-related emergency hospitalisation rate (time frame: First cycle of treatment of 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04263948, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.